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US safety concerns delay Astellas/Cardiome's Kynapid

 
• By Sue Sutter

A new clinical trial could be required for approval of [C#198600364:Astellas]/[C#199200060:Cardiome] Pharma's novel atrial fibrillation therapy Kynapid (vernakalant HCl injection) in the US, where FDAconcerns about potential cardiovascular adverse events have delayed licensing.

A new clinical trial could be required for approval of Astellas/Cardiome Pharma's novel atrial fibrillation therapy Kynapid (vernakalant HCl injection) in the US, where FDAconcerns about potential cardiovascular adverse events have delayed licensing.

On August 11th the companies announced receipt of an FDA letter deeming the drug approvable. The letter was issued almost...

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